Parenteral nutrition stability

Peroxide formation has also been observed in multivitamin solutions for parenteral nutrition. Lavoie and co-workers [30] have studied the action of light, air, and composition on the stability of multivitamin formulations, and also total parenteral nutrition (TPN) admixtures containing and not containing vitamins and fatty acids. They analyzed the generation of peroxide in multivitamin solutions and in TPN for adults and neonates. The analysis of multivitamin solutions for enteral use revealed the presence of peroxides at the initial opening of the bottle. The levels were higher in Poly-Vi-Sol (vitamin A, Vitamin D, and vitamin C, vitamin Bb riboflavin, and... 

Their use as an injectable warrants assurance of product sterility. Whereas the FDA-preferred heat-sterilization process is acceptable for total parenteral nutritional (TPN) emulsions, it could affect chemical as well as physical stability of emulsions containing therapeutic agents. Recently, data supporting the Liter sterilization of emulsions have been published. 

LDPE and PTFE are manufactured by processes involving little contact with metals, and should not be a major source of aluminum. On the other hand, HDPE and PP have similar manufacturing processes, based on catalysis, that involve aluminum, among other metals. The contamination risk may therefore be very high. In addition, the manufacture of the container itself can lead to aluminum contamination, considering the use of lubricants, stabilizers and other additives. For example, metal soaps, such as aluminum, magnesium, sodium, and tin, were sanctioned by the FDA to be used as stabilizers in plastic containers for parenteral nutrition solutions [76]. 

Shine B, Farwell JA. Stability and compatibility in parenteral nutrition solutions. Br J Parent Ther 1984 5 44-46. 

Smith JL, Canham JE, Wells PA. Effect of phototherapy light, sodium bisulfite, and pH on vitamin stability in total parenteral nutrition admixtures. J Parent Enter Nutr 1988 12 394-402. 

Schmutz CW, Martinelli E, Miihlebach S. Stability of vitamin Kj assessed by HPLC in total parenteral nutrition (TPN) admixtures. Clin Nutr 1992 ll(suppl) 110-lll. Billion-Rey F, Guillaumont M, Frederich A. Stability of fat-soluble vitamins A (retinol pabnitate), E (tocopherol acetate), and Kj (phylloquinone) in total parenteral nutrition at home. J Parent Enter Nutr 1993 17 56-60. 

Chen MF, Boyce W, Triplett L. Stability of the B vitamins in mixed parenteral nutrition solution. J Parent Enter Nutr 1983 7 462-464. 

Washington, C. The stability of intravenous fat emulsions 33. in total parenteral nutrition mixtures. Int. J. Pharm. 1990,... 

Hornsby-Lewis L, Shike M, Brown P, Klang M, Pearlstone D, Brennan MF. L-glutamine supplementation in home total parenteral nutrition patients stability, safety, and effects on intestinal absorption. J Parenter Enteral Nutr 1994 18(3) 268-73. 

Allwood MC. Factors influencing the stability of ascorbic acid in total parenteral nutrition infusions. J Clin Hosp Pharm 1984 9 75-85. 

Other incompatibilities include the inactivation of certain types of insulin due to the chelation of zinc, and the chelation of trace metals in total parenteral nutrition (TPN) solutions following the addition of TPN additives stabilized with disodium edetate. Calcium disodium edetate has also been reported to be incompatible with amphotericin and with hydralazine hydrochloride in infusion fluids. 

Lecithins are mainly used in pharmaceutical products as dispersing, emulsifying, and stabilizing agents and are included in intramuscular and intravenous injections, parenteral nutrition formulations, and topical products such as creams and ointments. 

Additionally, sodium bicarbonate is used in solutions as a buffering agent for erythromycin, lidocaine, local anesthetic solutions, and total parenteral nutrition (TPN) solutions. In some parenteral formulations, e.g., niacin, sodium bicarbonate is used to produce a sodium salt of the active ingredient that has enhanced solubility. Sodium bicarbonate has also been used as a freeze-drying stabilizer and in toothpastes. 

Manning RJ, Washington C. Chemical stability of total parenteral nutrition mixtures. Int J Pharm 1992 81 1-20. 

Comments an equimolecular mixture of dextrose and fructose prepared by the hydrolysis of sucrose with a suitable mineral acid such as hydrochloric acid. Invert sugar may be used as a stabilizing agent to help prevent crystallization of sucrose syrups and graining in confectionery. A 10% aqueous solution is also used in parenteral nutrition. 

The chapter should allow an appreciation of the factors leading to emulsion stability and physical instability, including flocculation and coalescence. Approaches to the formulation of emulsions to provide vehicles for drug delivery and parenteral nutrition (the main uses in pharmacy) should be understood. 

T. L. Whateley, G. Steele, J. Urwin and G. A. Small. Particle size stability of Intralipid and mixed total parenteral nutrition mixtures. /. Clin. Hosp. Pharm., 9, 113-26(1984)... 

Whateley TL, Steele G, Urwin J, Small GA. Particle size stability of intralipid and mixed total parenteral nutrition mixtures. J Clin Hosp Pharm 1984 9 113-126. 

Mirtallo JM, Rogers KR, Johnson JA, et al. Stability of amino acids and the availability of acid in total parenteral nutrition solutions containing hydrochloric acid. Am J Hosp Pharm 1981 38 1729-1731. 

Therefore, micelle-forming surfactant molecules (e.g., SDS) will be present in three different forms, namely, on the lipid surface, as micelles, and as monomeric surfactant molecules in solution. Lecithin will form liposomes, which have also been detected in nanoemulsions for parenteral nutrition [77], Mixed micelles have to be considered in glycocholate/lecithin-stabilized and -related systems. Micelles, mixed micelles, and liposomes are known to solubilize drugs, and are therefore attractive alternative drug-incorporation sites (especially with respect to the low incorporation capacity of lipid crystals). 

Preparations for total parenteral nutrition (TPN) are complex formulations intended for administration by the intravenous route. TPN preparations are formulated as aqueous solutions or hydrophilic (oil-in-water) emulsions they may contain amino acids, carbohydrates, fatty acids, emulsifiers, electrolytes, trace metals, vitamins, and minerals (Hutchinson, 1998 Trissel, 2001). In certain cases, drugs are added to the preparations prior to administration. The environment is thus rather heterogeneous, and the photochemical stability of different components can vary from formulation to formulation and be hard to predict. It is necessary to perform experiments based on studies of the actual composition to obtain correct information concerning photostability of the formulation or components present. 

Billionrey, F., Guillaumont, M., Frederich, A., and Aulagner, G. (1993) Stability of fat-soluble vitamin A (retinol palmitate), vitamin E (tocopherol acetate), and vitamin K1 (phyl-loquinone) in total parenteral nutrition at home, JPEN J. Parenter. Enteral. Nutr., 17, 56-60. 

The consequence.s arising from these new (rfjservations are considerable. EHie to the free phospholipid in fat emulsions used for parenteral nutrition there is an inciea.se in serum cholesterin level (5) and abnormal lipoproteins are formed (61.115). Both of these phenomena are more pronounced with 10 emulsions that have a higher amount of free phospholipid. As a result of these findings in the meantime emulsion.s are being produced that are stabilized with less lecithin (0.6-0.895 M19). 

The stability of colloidal emulsions—also due to the unexplained sinic-ture—is very difficult to foresee, as particularly in mixtures for total parenteral nutrition (TPN) there are many interactions. In a. series of anictes Washington attempted to put the prediction of stability of emulsions in TPN regimes on a rational basis (183-189). To explain the stability of emulsions the following effects and theories are referred to ... 

L. lllano, M, Delanghe, H. van den Baviere, and A. Lauwers. Effeet.s of electrolytes in the presence of some trace elements on the stability of all-in-one emulsion mixtures for total parenteral nutrition. J, Clin. Hosp. Pharm., 9 87-93, 1984. 

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